Regulatory Specialist - Rsch Pro 2-Reg Affairs University of MinnesotaRegulatory Specialist - Rsch Pro 2-Reg AffairsMinneapolis, MN$66,000–$85,000 / yearLocated at the heart of one of the nations most vibrant, diverse metropolitan communities, students on the campuses in Minneapolis and St. Paul benefit from extensive partnerships with world-renowned health centers, international corporations, government agencies, and arts, nonprofit, and public service organizations. Along with study coordinators, assist with scheduling and hosting monitoring visits conducted by internal and external entities, help to resolve findings and report the visits to internal University partners.
Senior Clinical Study Manager Inspire therapySenior Clinical Study ManagerMinneapolis, MinnesotaManage study safety by tracking and reporting adverse events as required by regulatory bodies, reviewing adverse event trends, and overseeing safety committees including Clinical Events Committees and Data Safety Monitoring Boards. Oversee monitoring activities related to assigned clinical studies including review and approval of monitoring plan and monitoring reports, managing monitoring schedule and ensuring corrective action related to monitoring findings.
Senior Clinical Study Manager Inspire Medical Systems Inc.Senior Clinical Study ManagerMinneapolis, MN$106,000–$170,000 / yearManage study safety by tracking and reporting adverse events as required by regulatory bodies, reviewing adverse event trends, and overseeing safety committees including Clinical Events Committees and Data Safety Monitoring Boards. Oversee monitoring activities related to assigned clinical studies including review and approval of monitoring plan and monitoring reports, managing monitoring schedule and ensuring corrective action related to monitoring findings.
Clinical Quality Manager Medtronic PlcClinical Quality ManagerMounds View, MNIf you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
Director, Clinical Affairs of Coronary/Vascular PhilipsDirector, Clinical Affairs of Coronary/VascularPlymouth, MN$171,000–$273,000 / yearYou're the right fit if: You've acquired 10+ years of directly related clinical or scientific experience, including leadership or management experience within the medical device industry, and 5+ years managing a clinical research functional team with a proven track record delivering complex clinical programs on time, within budget, and in compliance with applicable requirements. Your skills include comprehensive knowledge of clinical research regulations across multiple regions, FDA medical device regulations, medical device clinical trial practices, Good Clinical Practice, informed consent requirements, regulatory documentation, and the clinical evidence requirements needed to support regulatory, product development, and commercial objectives.
Director, Clinical Affairs Of Coronary/Vascular PhilipsDirector, Clinical Affairs Of Coronary/VascularPlymouth, MN$171,000–$273,000 / yearYou're the right fit if: You've acquired 10+ years of directly related clinical or scientific experience, including leadership or management experience within the medical device industry, and 5+ years managing a clinical research functional team with a proven track record delivering complex clinical programs on time, within budget, and in compliance with applicable requirements. Your skills include comprehensive knowledge of clinical research regulations across multiple regions, FDA medical device regulations, medical device clinical trial practices, Good Clinical Practice, informed consent requirements, regulatory documentation, and the clinical evidence requirements needed to support regulatory, product development, and commercial objectives.